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Active, not recruitingNCT04294199Updated Dec 18, 2023

Effect of Early Range of Motion Following First Time Patellar Dislocation

An interventional study of Early Range of MOtion in Patellar Dislocation, sponsored by Baylor College of Medicine. Active, not recruiting at 1 site in United States. Open to participants aged 11 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-12-18.

Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as active, not recruiting.
  • Registered 1 year 4 months after the study started (first participant enrolled Oct 2018, registered Mar 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
11 Years to 17 Years
Sex
All
01

Study summary

Do teen-age patients with a dislocated knee cap do better with or without a brace?

Read the detailed description

This study will look at two different ways to treat teen-age patients who have had a dislocation of their knee cap. Both groups will receive the physical therapy treatment for knee cap dislocation but one group will first be in a brace for a week and the other group will start moving in therapy right away.

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Conditions studied

  • Patellar Dislocation

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03

In context

Patellar Dislocation

41 studies on the registry are indexed under Patellar Dislocation; 9 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 22 interventional studies indexed under Patellar Dislocation.

Browse Patellar Dislocation studies →

Lead sponsor

Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.

Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
11 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male and female adolescents between 11-17 years
  • Medical diagnosis of 1st time lateral patellar instability episode (dislocation or subluxation)
  • Subjective history of knee shifting, instability, popping out, knee effusion
  • Apprehension test is positive and has medial patellar tenderness
  • Referred to the Texas Children's Hospital (TCH) outpatient sports medicine clinic from an emergency room facility, urgent care or pediatrician within 10 days of the injury.
  • Free of co-morbidities that would prevent or limit rehabilitation including cardiac, pulmonary, psychiatric (except Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD), orthopedic, neurological
  • Must be able to follow directions and participate in rehabilitation protocol for the 3-month study period.

Exclusion criteria

Exclusion Criteria:

  • Imaging or clinical findings suggest surgical intervention is needed i.e. fracture, osteochondral defect, Lachman or other positive knee ligament special tests.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Immobilization

    Patients in this group will be given a knee immobilizer to wear for 2 weeks and then receive outpatient physical therapy evaluation and treatment

    Other: Early Range of MOtion

  • Experimental
    Early range of motion

    Patients in this group will be allowed to move the knee and start outpatient physical therapy and treatment immediately.

    Other: Early Range of MOtion

Interventions

  • OtherEarly Range of MOtion

    Groups will be compared to see if immobilization or early range of motion is better at returning to their sport after patellar dislocation.

    Also known as: Immobilization, Ear;y Range of Motion

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What researchers measure

Primary outcomes

  1. Kujala Knee Score

    13 item questionnaire to rate pain, function, ambulation, and instability

    Time frame: 10 minutes

  2. Tegner Activity Scale

    11 levels of activity from complete inability to function to advanced sports participation

    Time frame: 5 minutes

  3. Isokinetic Strength using Biodex

    Force of movement is measured in newtons and torque and corrected for body weight

    Time frame: 30 minutes

  4. Passive Range of Motion

    Measured with goniometer to record full range of motion in knee flexion and extension

    Time frame: 5 minutes

  5. Edema Assessment

    Measure of knee circumference

    Time frame: 2 minutes

Secondary outcomes

  1. Numerical Pain Rating Scale

    Pain rated by patient on scale of 0-10.

    Time frame: 1 minute

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Study locations

1 site
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References and documents

Publications

  • Erickson BJ, Mascarenhas R, Sayegh ET, Saltzman B, Verma NN, Bush-Joseph CA, Cole BJ, Bach BR Jr. Does Operative Treatment of First-Time Patellar Dislocations Lead to Increased Patellofemoral Stability? A Systematic Review of Overlapping Meta-analyses. Arthroscopy. 2015 Jun;31(6):1207-15. doi: 10.1016/j.arthro.2014.11.040. Epub 2015 Jan 28. PubMed 25636989 ↗
  • Armstrong BM, Hall M, Crawfurd E, Smith TO. A feasibility study for a pragmatic randomised controlled trial comparing cast immobilisation versus no immobilisation for patients following first-time patellar dislocation. Knee. 2012 Oct;19(5):696-702. doi: 10.1016/j.knee.2011.08.004. Epub 2011 Sep 29. PubMed 21962458 ↗
  • Saccomanno MF, Sircana G, Fodale M, Donati F, Milano G. Surgical versus conservative treatment of primary patellar dislocation. A systematic review and meta-analysis. Int Orthop. 2016 Nov;40(11):2277-2287. doi: 10.1007/s00264-015-2856-x. Epub 2015 Jul 23. PubMed 26202017 ↗
  • Cheng B, Wu X, Ge H, Qing Sun Y, Zhang Q. Operative versus conservative treatment for patellar dislocation: a meta-analysis of 7 randomized controlled trials. Diagn Pathol. 2014 Mar 18;9:60. doi: 10.1186/1746-1596-9-60. PubMed 24636710 ↗
  • Matic GT, Magnussen RA, Kolovich GP, Flanigan DC. Return to activity after medial patellofemoral ligament repair or reconstruction. Arthroscopy. 2014 Aug;30(8):1018-25. doi: 10.1016/j.arthro.2014.02.044. Epub 2014 Apr 24. PubMed 24768468 ↗
  • Vavken P, Wimmer MD, Camathias C, Quidde J, Valderrabano V, Pagenstert G. Treating patella instability in skeletally immature patients. Arthroscopy. 2013 Aug;29(8):1410-22. doi: 10.1016/j.arthro.2013.03.075. Epub 2013 May 25. PubMed 23714402 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2018 (actual). Primary completion is estimated for Jun 2024, 67 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 2, 2020
First posted
Mar 4, 2020
StartActual
Oct 31, 2018
Primary completionEst.
Jun 15, 2024
CompletionEst.
Aug 11, 2026
Last update
Dec 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04294199
Responsible party
Scott McKay (Principal Investigator, Baylor College of Medicine) — Principal investigator
First posted
Mar 4, 2020
Start date
Oct 31, 2018
Primary completion
Jun 15, 2024 (estimated)
Completion
Aug 11, 2026 (estimated)
Last update
Dec 18, 2023

Study contacts

Scott McKay, MD
principal investigator · Baylor College of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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